Women with abnormal serum thyroid antibody levels or abnormal TSH and/or T4 values are more likely than their normal counterparts to have higher scores on a common postpartum depression screening test...
Date First Received: November 27, 2007
Last Updated: January 22, 2008
Verified by: Oklahoma State University Center for Health Sciences, January 2008
Clinical Trial Phase: N/A | Start Date: January 2000
Overall Status: Completed
Estimated Enrollment: 75
Brief Summary
Official Title: “Postpartum Thyroid Measures and Mood”
Condition Keyword(s):
Women with abnormal serum thyroid antibody levels or abnormal TSH and/or T4 values are more likely than their normal counterparts to have higher scores on a common postpartum depression screening test.
Study Type: Observational
Study Design: Cohort, Prospective
Detailed Clinical Trial Description
This small pilot study was an attempt to corroborate a relationship between quantified mood and thyroid measures, using the numerical scores obtained from a common depression screen, the Edinburgh Postnatal Depression Scale (EPDS), as a continuum. Mood scores were compared with presence of thyroid autoantibodies and plasma concentrations of free T4 and TSH.
Outcome Measures for this Clinical Trial
Primary Measures
- Numerical score on the Edinburgh Postnatal Depression Scale
- Time Frame: seven weeks
- Time Frame: seven weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Over 18 years of age
- In third trimester of pregnancy when recruited
- Negative for the following drugs detected by a urine drug screen:
- Amphetamines
- Barbiturates
- Benzodiazepines
- Cocaine
- Opiates
- Phencyclidine metabolites (PCP), and tricyclic antidepressants
- Vaginal delivery
- Screened negative for major depressive disorder on the Edinburgh Postnatal
- Depression Scale (EPDS) at her prenatal enrollment in the study
- Receiving a score of 12 or lower out of a possible 30
Exclusion Criteria:
- Under age 18
- Positive for any of the following drugs:
- Amphetamines
- Barbiturates
- Benzodiazepines
- Cocaine
- Opiates
- Phencyclidine metabolites (PCP), and tricyclic antidepressants
- Cesarean delivery
- EPDS score over 12 at prenatal screening test
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 50 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Oklahoma State University Center for Health Sciences
Overall Clinical Trial Officials and Contacts
Gary H. Watson, PhD Study Director Philadelphia College of Osteopathic Medicine Georgia Campus
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00565032
Study ID Number: 9899015
ClinicalTrials.gov Identifier: NCT00565032
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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